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Dual REmission in Moderate-to-SEvere asthMa and Nasal Polyps

NCT07574294 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2026-05-07

No results posted yet for this study

Summary

Background: "Remission" is a primary therapeutic goal in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), though definitions vary regarding olfactory function. We evaluated "Dual Remission" kinetics in patients treated with dupilumab over 24 months. Methods: This single-center retrospective study analyzed 28 patients with comorbid severe asthma and CRSwNP. Dual Remission was defined as simultaneous asthma remission (Asthma Control Test (ACT) ≥ 20, no exacerbations, no oral corticosteroids (OCS) and stable lung function) and CRSwNP remission (Sino-Nasal Outcome Test-22 (SNOT-22) \< 40, Nasal Polyp Score (NPS) \> 1). We additionally analyzed "Complete Recovery" by applying a stricter composite definition requiring the restoration of normosmia (Sniffin' Sticks score \> 12). Results: At baseline, patients exhibited uncontrolled disease (median ACT 19, NPS 6). Treatment led to rapid asthma remission (85.7% at 12 months, 100% at 24 months). CRSwNP remission was slower but progressive, rising from 57% at 12 months to 88% at 24 months, demonstrating a significant "catch-up" phenomenon. Consequently, Dual Remission rates increased from 54% to 88% by month 24. When applying the stricter "Complete Recovery" criteria requiring normosmia, only 32% met the goal. Conclusion: Dupilumab is highly effective, enabling 88% of patients to achieve Dual Remission after 24 months. However, full olfactory restitution is distinct from structural polyp regression and harder to achieve, likely due to persistent neuroepithelial damage.

Conditions

  • Asthma
  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

OTHER

Not applicable- observational study

observational study

DRUG

Dupilumab

Retrospective multicentric observational study was performed on a cohort of 205 consecutive adult outpatients with comorbid asthma and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The study involved a total of 13 clinical centers across Italy, coordinated by the Multidisciplinary Pulmonology and Otolaryngology Unit of the S. Valentino Hospital in Montebelluna, Italy. All participating satellite centers followed a follow-up schedule similar to that of the coordinating center to ensure data consistency. All patients received dupilumab 300 mg every 15 days. A 600 mg loading dose was administered exclusively to the severe asthma group, following the approved summary of product characteristics. Clinical Endpoints and Definitions Data were collected at baseline (T0), 6 months (T6), 12 months (T12), and 24 months (T24).

Sponsors & Collaborators

  • Azienda Ulss 2 Marca Trevigiana

    lead OTHER

Principal Investigators

  • Francesco Menzella, Medicine and Surgery · Azienda Ulss 2 Marca Trevigiana

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574294 on ClinicalTrials.gov